IMKELDI
Details
- Status
- Prescription
- First Approved
- 2024-11-22
- Routes
- ORAL
- Dosage Forms
- SOLUTION
IMKELDI Approval History
What IMKELDI Treats
7 indicationsIMKELDI is approved for 7 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Chronic Myeloid Leukemia
- Acute Lymphoblastic Leukemia
- Myelodysplastic/Myeloproliferative Diseases
- Systemic Mastocytosis
- Hypereosinophilic Syndrome
- Chronic Eosinophilic Leukemia
- Dermatofibrosarcoma Protuberans
IMKELDI Target & Pathway
ProTarget
An abnormal fusion protein created by a chromosomal translocation, found in chronic myeloid leukemia (CML). BCR-ABL has constitutive kinase activity that drives leukemic cell proliferation. Targeting BCR-ABL transformed CML from a fatal disease to a manageable condition.
IMKELDI Competitors
Pro5 other drugs also target BCR-ABL. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (BCR-ABL). Earlier expiry dates signal biosimilar/generic opportunities.
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
IMKELDI FDA Label Details
ProIndications & Usage
FDA Label (PDF)Imkeldi is a kinase inhibitor indicated for the treatment of: Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy. Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblast...
IMKELDI Patents & Exclusivity
Patents (1 active)
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.